Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+

Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression

In the vast majority of those infected with HIV virus who are untreated, there is deterioration in immune health over a period of months or years inevitably leading to full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if started before a certain degree of progression occurs and has saved millions of lives. The investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably to ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.

Study Overview

• Status: Completed
• Conditions: HIV Seropositivity
• Intervention / Treatment: Drug: Naltrexone; Drug: Naltrexone + ARV's; Other: ARV's + Placebo

Detailed Description

The LDN (low-dose naltrexone) vs ARV (anti-retroviral drugs) Effectiveness Study in Mali sponsored by The Ojai Foundation in California-USA is a clinical research study endorsed and approved by the Malian Government. Naltrexone hydrochloride is a generic, FDA-approved since 1998 drug, an opioid antagonist that has clinically shown immune enhancing/modulating qualities in very low dosage and may offer an alternative to ARV drugs that is effective, non-toxic, easily available, inexpensive, with simple once-daily at bedtime administration. LDN capsules must be created by compounding pharmacists to get these ultra-small doses. Due to toxicity of current ARV drugs and need for special medical management young HIV infected children are largely neglected particularly in developing countries; LDN can also be made available in a transdermal cream for infants and children who are HIV infected.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mali
  • Bamako, Mali, BP0 Box 333
    • University Hospital of Point G

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV-1 infected
• CD4 count over 350 (arm 1/group 1)
• CD4 count over 200 and on ARV's (arms 2,3/groups 2,3)
• Age between 18 & 60
• Males or females

Exclusion criteria:

• HIV-1 seronegative
• HIV-2 infected
• CD4 count lower than 200
• patients under age 18
• Those refusing to be in study
• Pregnant or breast-feeding women
• Patients under immuno-suppressor therapy
• Those with renal or hepatic dysfunction
• Malaria or tuberculosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naltrexone Low-dose 3mg capsule; Each person in this arm 1 of the study had never received any ARV drugs and in this study received only one Low-Dose Naltrexone 3mg capsule nightly for 9 months (no placebo).	Drug: Naltrexone; Naltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months
Active Comparator: Naltrexone Low Dose + ARVs; In this Arm 3, Patients were on ARV's plus being given Naltrexone Low-Dose (3mg) once daily at bedtime for 9 months.	Drug: Naltrexone + ARV's; Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.; Other Names: Azidothimidine + lamivudine + nevirapine Or; Stavudine + lamivudine + nevirapine (TRIOMUNE)Or; Azidothimidine + lamivudine + efavirenz Or; Azidothimidine + lamivudine + lopinavir/r Or; Emtricitabine + tenofovir + efavirenz
Placebo Comparator: ARV's (continued,standard) plus Placebo; In this arm 2, patients were started or continued on their standard ARV drugs plus placebo capsule once daily at bedtime; in the 2nd and 3rd arms patients did not know whether they were taking Low-Dose Naltrexone or a placebo.	Other: ARV's + Placebo; Patients continued ARV's plus a placebo nightly for 9 months; Other Names: Azidothimidine + lamivudine + nevirapine Or; Stavudine + lamivudine + nevirapine (TRIOMUNE)Or; Azidothimidine + lamivudine + efavirenz Or; Azidothimidine + lamivudine + lopinavir/r Or; Emtricitabine + tenofovir + efavirenz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4+ percentage (change in HIV-1 seropositive patients)	HIV+ patients with CD4+ count over 350 had their CD4 count/percentage measured at beginning, at 15 days, at 1 month, 3 months, 6 months and 9 months (end).	9 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment of evidence of AIDS or other serious illness	HIV+ patients with CD4 counts over 200 on ARV drugs were given clinical assessment and testing for evidence of opportunistic infections (AIDS) at each visit for blood testing: (Beginning, 15 days, 1 month, 3 months, 6 months, & 9 months (end).	9 MONTHS

Collaborators and Investigators

• Sponsor: The Ojai Foundation
• Investigators: Principal Investigator: Abdel K Traore, MD, Professor, Bamako University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: August 2, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 4, 2010

Study Record Updates

• Last Update Posted (Estimate): August 4, 2010
• Last Update Submitted That Met QC Criteria: August 2, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Sensory System Agents; Antimetabolites; Protease Inhibitors; Narcotic Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Alcohol Deterrents; HIV Protease Inhibitors; Viral Protease Inhibitors; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Tenofovir; Emtricitabine; Nevirapine; Naltrexone; Lopinavir; Lamivudine; Stavudine; Efavirenz; Stavudine, lamivudine, nevirapine drug combination
• Other Study ID Numbers: TOFLDNMALIHIVb